Okamoto
⚠️ Moderate Risk
FEI: 3006029595 • Bridgeport, CT • UNITED STATES
FEI Number
3006029595
Location
Bridgeport, CT
Country
UNITED STATESAddress
18 King St, , Bridgeport, CT, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Okamoto's FDA import refusal history?
Okamoto (FEI: 3006029595) has 1 FDA import refusal record(s) in our database, spanning from 3/6/2007 to 3/6/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Okamoto's FEI number is 3006029595.
What types of violations has Okamoto received?
Okamoto has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Okamoto come from?
All FDA import refusal data for Okamoto is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.